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510(k) Data Aggregation
(102 days)
ZIBO HUAQI TRADING Co., Ltd
The Powder Free Yellow Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The proposed device, Powder Free Yellow Vinyl Patient Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. The proposed is Powder Free Yellow Vinyl Patient Examination Gloves, and includes variations of different size.
The provided text describes the 510(k) summary for "Powder Free Yellow Vinyl Patient Examination Gloves." This is a premarket notification for a Class I medical device (patient examination glove), which is regulated under 21 CFR 880.6250. The submission aims to demonstrate substantial equivalence to a predicate device (K091431).
Given that this is a 510(k) submission for a low-risk device like examination gloves, the "acceptance criteria" primarily relate to compliance with recognized standards and demonstrating equivalence to a predicate device rather than complex clinical endpoints or AI model performance. The "study" here refers to bench tests and biocompatibility assessments.
Here's a breakdown based on your request:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from recognized standards (ASTM, ISO) and comparison to the predicate device. The reported performance aligns with these standards.
| Acceptance Criteria (from Standards / Predicate) | Reported Device Performance (Proposed Device) | Remark |
|---|---|---|
| Material | ||
| Vinyl | Vinyl | SE |
| Dimensions (all sizes) | ||
| Length: ≥ 240 mm | 240 mm (min) | SE |
| Width: ±5 mm (e.g., S: 85mm) | S: 85 mm, M: 95 mm, L: 105 mm, XL: 115 mm (±5 mm) | SE |
| Thickness: Finger: ≥ 0.10 mm | 0.10 mm (min) | SE |
| Thickness: Palm: ≥ 0.08 mm | 0.08 mm (min) | SE |
| Thickness: Cuff: ≥ 0.06 mm | 0.06 mm (min) | SE |
| Physical Properties (Before Aging) | ||
| Tensile Strength: ≥ 13 MPa | 13 MPa, min | SE |
| Ultimate Elongation: ≥ 400% | 400 % min | SE |
| Physical Properties (After Aging) | ||
| Tensile Strength: ≥ 13 MPa | 13 MPa, min | SE |
| Ultimate Elongation: ≥ 400% | 400 % min | SE |
| Comply with ASTM D5250 | Comply with ASTM D5250 | SE |
| Freedom from Holes | ||
| Be free from holes when tested in accordance with ASTM D5151 | Be free from holes when tested in accordance with ASTM D5151 | SE |
| Powder Content | ||
| Meet ASTM D5250 requirements (for powder-free) | 0.61 mg per glove | SE |
| Biocompatibility | ||
| Irritation: Not an irritant (Comply with ISO 10993-10) | Under the conditions of the study, not an irritant | SE |
| Sensitization: Not a sensitizer (Comply with ISO 10993-10) | Under conditions of the study, not a sensitizer | SE |
| Label and Labeling | ||
| Meet FDA's Requirements | Meet FDA's Requirements | SE |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly mentions the use of ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection." This standard details how sample sizes are determined for inspection based on the lot size and acceptable quality levels for attributes like holes, dimensions, and physical properties.
- Sample Size: While the exact number of gloves or batches tested is not explicitly stated in this summary, it refers to ISO 2859-1 for sampling procedures, implying that samples were drawn from production lots according to this standard. For biocompatibility, standard practice involves a sufficient number of samples to represent the device and achieve statistically significant results (e.g., typically 3 device samples for in vitro tests, and appropriate animal numbers for in vivo tests as per ISO 10993-10).
- Data Provenance: The tests were conducted by Zibo Huaqi Trading Company, Limited, which is based in China. The nature of these tests (bench tests, biocompatibility) implies they were prospective in the sense that they were specifically designed and executed for this 510(k) submission on samples of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable to this type of device. "Ground truth" and "experts" in the context of clinical interpretation (like radiologists) are relevant for diagnostic imaging or AI devices. For patient examination gloves, the "ground truth" is established by direct physical measurements, chemical analysis, and standardized biological assessments conducted by trained lab personnel following the protocols outlined in the referenced ASTM and ISO standards. There are no clinical interpretation experts involved in establishing the "ground truth" for the physical and biological characteristics of a glove.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers assess cases and a consensus or tie-breaker mechanism is used to establish ground truth, particularly in the context of diagnostic performance or AI evaluation. For bench testing of gloves, results are typically objective measurements or observations (e.g., pass/fail for holes, numerical values for tensile strength) that do not require clinical adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This device is a disposable patient examination glove; it does not involve any AI, human readers, or diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is entirely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical glove, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of these gloves is established through adherence to recognized international and national standards (ASTM D5250, ASTM D5151, ASTM D6124, ISO 2859-1, ISO 10993-10). The "truth" is whether the glove samples meet the specified physical, dimensional, and biological requirements outlined in these standards. This involves:
- Direct Physical Measurement: For dimensions (length, width, thickness).
- Controlled Testing Procedures: For tensile strength, elongation, hole detection, powder content.
- Standardized Biocompatibility Tests: According to ISO 10993-10 for irritation and sensitization, which involves animal or in vitro tests as specified by the standard.
There is no "expert consensus" in the clinical sense, pathology, or outcomes data used to establish glove ground truth.
8. The sample size for the training set
This section is not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI. The manufacturer's production processes and quality control systems would be refined over time (akin to "training" in a broad sense), but there is no specific quantifiable training set size as for an algorithm.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8. There is no training set for a physical device. The manufacturing process is validated against specifications to ensure consistent quality.
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